Visual Health Evaluation of New Designed Blue-blocking Glasses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Critical flicker fusion frequency
研究概览
简要总结
With the widespread use of electronic display devices, the potential hazards of blue light have become an important public health issue. The primary assessment and main outcome indicators of this experiment are the evaluation of the protective effects of a new type of filtering glasses on visual fatigue in the human eye. Secondary outcome indicators include tear film break-up time, accommodative facility, and subjective visual fatigue scores. Other outcome measurement indicators include visual function indicators such as accommodation and convergence. Baseline values of the above indicators were measured separately, and then specific numerical values of different indicators were collected after working with VDT devices while wearing the new type of filtering glasses or regular framed glasses. These values were statistically compared and analyzed with the baseline values. The study aims to assess the impact of the new type of filtering glasses on relieving visual fatigue and improving visual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Adult population, regardless of gender
- •Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher.
- •Normal intraocular pressure with no organic pathology.
- •No apparent symptoms of dry eye.
- •Willing to cooperate to complete all the tests.
- •Voluntarily signing the informed consent form.
排除标准
- •1: Individuals with strabismus and amblyopia exist. 2: Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
- •3: Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
- •4: Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
- •5: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
- •6: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
- •7: Only one eye meets the inclusion criteria. 8: Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
- •9: Currently using medications that may lead to dry eye or affect vision and corneal curvature.
- •10: Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
- •11: Unable to undergo regular eye examinations.
研究组 & 干预措施
A Group
Is a group that will first wear the new type of filtering glasses for one week of observation, followed by one week of observation wearing regular framed glasses. In this trial group, participants will initially perform VDT (Visual Display Terminal) work while wearing the new filtering glasses for at least two hours per day. On the first afternoon, after wearing blue-light-blocking glasses for two hours of near work on VDT, participants will undergo data collection for the trial (including critical flicker fusion frequency (CFF), binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.), followed by a visual fatigue questionnaire survey after completing the tasks. For a continuous period of one week, participants will wear blue-light-blocking glasses for at least two hours of near work on VDT each day, and on the seventh afternoon, they will undergo another round of data collection and complete the visual fatigue questionnaire survey.
干预措施: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. (Combination Product)
B Group
Is a trial group that first wears regular framed glasses for one week of observation, followed by one week of observation wearing a new type of filtering glasses. In this trial group, subjects will first engage in VDT (Visual Display Terminal) work wearing regular framed glasses for at least two hours per day. On the afternoon of the first day, after wearing regular framed glasses for two hours of near work with VDT, experimental data will be collected (including CFF, binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.). After completing the tasks, a visual fatigue questionnaire will be conducted. For a continuous period of one week, subjects will wear blue-light filtering glasses for at least two hours of near work with VDT each day. On the afternoon of the seventh day, experimental data collection and a visual fatigue questionnaire will be conducted again.
干预措施: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. (Combination Product)
结局指标
主要结局
Critical flicker fusion frequency
时间窗: Participants underwent two randomized experimental conditions. For each condition, CFF test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
CFF was measured before and after the task by a flicker fusion frequency detection device to assess changes in the degree of ocular fatigue. To compare the difference in CFF after wearing anti-blue glasses with normal glasses and to evaluate the effect of anti-blue glasses in preventing asthenopia.
次要结局
- Visual fatigue(Participants underwent two randomized experimental conditions. For each condition, visual fatigue questionnaires were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.)
- Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks(Participants underwent two randomized experimental conditions. For each condition, flip- chart tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.)
- Break up time(Participants underwent two randomized experimental conditions. For each condition, BUT tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.)
- AC/A Ratio Measurement Post-VDT Tasks(Participants underwent two randomized experimental conditions. For each condition, AC/A ratio test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.)
- equivalent refraction(Participants underwent two randomized experimental conditions. For each condition, SE test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.)